A Multicentre Comparative Trial of Efficacy and Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) Versus Combination of SSG and PM as the First Line Treatment for Visceral Leishmaniasis in Ethiopia, Kenya and Sudan

Brief Summary

The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21 days alone and SSG and PM as a combination course of 17 days in the treatment of patients with VL.

Detailed Description

Currently in the three countries, Sudan, Kenya and Ethiopia many of the patients present themselves in remote areas and need to be treated in relative resource poor settings. It is for this reason that standardised treatment with proven efficacy is much needed. A shorter course of treatment is not only advantageous for the patient but also reduces the overall case load in the clinics thus reducing the risk of disease outbreaks in already immuno-compromised kala-azar patients. Paromomycin, either alone or in combination with SSG would decrease the treatment duration substantially. An additional added value of combination therapy is that it is likely to reduce the chances of development of parasite resistance against the individual drugs.

Leishmaniasis experts in the three countries are in agreement that there are potential benefits of the combination treatment of SSG and PM and that its efficacy should be evaluated with the view to introduce this protocol if proven efficacious and safe. There is ample circumstantial evidence of the use of this combination therapy and its efficacy and tolerability as a standardized protocol. This can only be confirmed through a randomised controlled study with 6 months follow up.

Patients with severe protein and or caloric malnutrition (Kwashiokor or marasmus)

Patients with previous hypersensitivity reaction to SSG or aminoglycosides.

Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patients response to study medication.

Patients suffering from other conditions associated with splenomegaly such as schistosomiasis.

Patients with previous history of cardiac arrhythmia or an abnormal ECG

Patients who are pregnant or lactating.

Patients with haemoglobin < 5gm/dl.

Patients with WBC < 1 x 10³/mm³.

Patients with platelets < 40,000/mm³.

Patients with liver function tests more than three times the normal range

Patients with serum creatinine outside the normal range for age and gender

Patients with pre-existing clinical hearing loss.

Gender

Both

Ages

4 Years to 60 Years

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects